OHTUVAYRE Drug Patent Profile

Which patents cover Ohtuvayre, and what generic alternatives are available?

Ohtuvayre is a drug marketed by Verona Pharma and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in thirty countries.

The generic ingredient in OHTUVAYRE is ensifentrine. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.

DrugPatentWatch^® Generic Entry Outlook for Ohtuvayre

Ohtuvayre will be eligible for patent challenges on June 26, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 26, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OHTUVAYRE

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in OHTUVAYRE?	OHTUVAYRE excipients list
DailyMed Link:	OHTUVAYRE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OHTUVAYRE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217389

Dosage:

SUSPENSION;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for OHTUVAYRE

OHTUVAYRE is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	9,956,171		Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	9,062,047			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	10,945,950		Y

International Patents for OHTUVAYRE

See the table below for patents covering OHTUVAYRE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2483801
Malaysia	157432	CRYSTALLINE FORM OF PYRIMIDO [6, 1-A] ISOQUINOLIN-4-ONE COMPOUND
China	111249260	包含RPL554的液体吸入制剂 (Liquid inhalation formulation comprising RPL554)
Portugal	2603509
Denmark	3332767
Croatia	P20180833
Hong Kong	1249415	包含RPL554的液體吸入製劑 (LIQUID INHALATION FORMULATION COMPRISING RPL554)

OHTUVAYRE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ohtuvayre

Introduction to Ohtuvayre

Ohtuvayre (ensifentrine) is a groundbreaking treatment for Chronic Obstructive Pulmonary Disease (COPD), developed by Verona Pharma and manufactured by Ritedose. The FDA approved Ohtuvayre on June 26, 2024, marking the first new mechanism of action in COPD treatment in over 20 years[1].

Mechanism of Action and Clinical Significance

Ohtuvayre is a first-in-class PDE3 and PDE4 inhibitor, delivered via a standard jet nebulizer. This dual inhibition mechanism offers a novel approach to addressing both bronchodilation and anti-inflammatory effects simultaneously, potentially providing superior symptom control compared to current therapies[1].

Market Impact

The COPD market is ripe for innovation, with a global patient population exceeding 480 million and 14 million in the US. Ohtuvayre's entry into this market could significantly alter market dynamics. If it demonstrates superior efficacy, it could rapidly gain market share from established players like GSK and AstraZeneca[1].

Partnership and Manufacturing

The partnership between Verona Pharma and Ritedose is strategically important. Ritedose, the largest CDMO in the US specializing in sterile Blow Fill Seal production, brings manufacturing expertise that complements Verona's innovation. This collaboration could lead to increased market share for both companies in the lucrative COPD market[1].

Financial Trajectory

Revenue Projections and Milestones

The successful launch of Ohtuvayre has already shown promising results. Verona Pharma reported quarterly net sales of $5.6 million, with October sales alone exceeding the entire third quarter. This robust start is expected to contribute significantly to royalty revenues for Ligand, which has a royalty agreement with Verona Pharma[2].

Ligand raised its 2024 revenue forecast to $100-$165 million, with adjusted EPS between $5.50 and $5.70, partly due to the successful launches of Ohtuvayre and other drugs. The company also earned a $13.5 million milestone payment from Verona following the commercial launch of Ohtuvayre[2].

Long-term Growth Potential

The long-term financial outlook for Ohtuvayre is optimistic. With its unique mechanism of action, Ohtuvayre is poised to become a significant driver of royalty revenue. Ligand projects a long-term royalty revenue CAGR of over 22% and adjusted core EPS growth above 25% CAGR through 2028[2].

Investor Interest and Market Valuation

Successful commercialization of Ohtuvayre could transform Verona Pharma from a clinical-stage to a commercial-stage company, potentially leading to increased investor interest and market valuation. The robust start to the US launch and the significant milestone payments are indicators of this potential[2].

Challenges and Considerations

Real-World Efficacy and Safety

While Ohtuvayre's approval is a significant milestone, long-term real-world efficacy and safety data will be crucial. The nebulizer delivery method may also impact patient adherence, as some patients prefer more portable inhaler devices[1].

Market Competition

The COPD market is competitive, and Ohtuvayre will need to compete with established treatments. However, its novel mechanism of action and potential for superior symptom control position it well to gain market share[1].

Industry Dynamics

Generic Drug Market Insights

Although Ohtuvayre is not a generic drug, understanding the dynamics of the generic drug market can provide insights into how competition evolves. Generic drug prices fall with the number of competitors, but remain above long-run marginal cost until there are 8 or more competitors. This suggests that innovative drugs like Ohtuvayre can maintain a competitive edge for a significant period[3].

Inhalation Drug Delivery Devices Market

The global inhalation drug delivery devices market is growing, driven by the need for effective treatments for respiratory diseases like COPD. Ohtuvayre's approval and its novel inhalation delivery method align with this market trend, indicating a favorable market environment[4].

Key Takeaways

• Innovative Mechanism: Ohtuvayre is the first inhaled product with a new mechanism of action in over 20 years, offering a dual PDE3 and PDE4 inhibition.
• Market Impact: It has the potential to significantly alter COPD market dynamics and gain market share from established players.
• Financial Trajectory: Robust launch results and significant milestone payments indicate a strong financial outlook.
• Challenges: Long-term efficacy and safety data, and patient adherence to the nebulizer delivery method, are key considerations.
• Industry Dynamics: The drug maintains a competitive edge in a market ripe for innovation.

FAQs

What is Ohtuvayre and how is it administered?

Ohtuvayre (ensifentrine) is a novel COPD treatment administered via a standard jet nebulizer. It is a first-in-class PDE3 and PDE4 inhibitor.

Who are the key partners involved in the development and manufacturing of Ohtuvayre?

Verona Pharma and Ritedose are the key partners, with Verona Pharma developing the drug and Ritedose manufacturing it.

What is the potential market impact of Ohtuvayre?

Ohtuvayre could significantly alter COPD market dynamics and gain market share from established players due to its novel mechanism of action.

What are the financial projections for Ohtuvayre?

The drug is expected to contribute significantly to royalty revenues, with Ligand raising its 2024 revenue forecast partly due to Ohtuvayre's successful launch.

What challenges might Ohtuvayre face in the market?

Ohtuvayre may face challenges related to long-term real-world efficacy and safety data, as well as patient adherence to the nebulizer delivery method.

Sources

1. Ritedose is Proud to Partner with Verona Pharma to Deliver First-In-Class COPD Drug, Ohtuvayre (ensifentrine)
   • https://www.stocktitan.net/news/VRNA/ritedose-is-proud-to-partner-with-verona-pharma-to-deliver-first-in-5cj8uoxllpvk.html
2. Earnings call: Ligand reports robust Q3 growth, raises 2024 forecast
   • https://www.investing.com/news/transcripts/earnings-call-ligand-reports-robust-q3-growth-raises-2024-forecast-93CH-3712777
3. Generic Drug Industry Dynamics
   • https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-industry-dynamics/industrydynamicsreiffenwp_0.pdf
4. Global Inhalation Drug Delivery Devices Market Report 2024 Edition
   • https://www.cognitivemarketresearch.com/inhalation-drug-delivery-devices-market-report